Primary Device ID | 00842430109188 |
NIH Device Record Key | 13a35d49-7447-4a8b-aac6-4731a32a2d47 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PRONECONNECT PROTECTIVE HELMET |
Version Model Number | PC501FH |
Catalog Number | PC501FH |
Company DUNS | 084527241 |
Company Name | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 1-800-777-4674 |
CustServ@mizuhosi.com | |
Phone | 1-800-777-4674 |
CustServ@mizuhosi.com | |
Phone | 1-800-777-4674 |
CustServ@mizuhosi.com | |
Phone | 1-800-777-4674 |
CustServ@mizuhosi.com | |
Phone | 1-800-777-4674 |
CustServ@mizuhosi.com | |
Phone | 1-800-777-4674 |
CustServ@mizuhosi.com | |
Phone | 1-800-777-4674 |
CustServ@mizuhosi.com | |
Phone | 1-800-777-4674 |
CustServ@mizuhosi.com | |
Phone | 1-800-777-4674 |
CustServ@mizuhosi.com | |
Phone | 1-800-777-4674 |
CustServ@mizuhosi.com | |
Phone | 1-800-777-4674 |
CustServ@mizuhosi.com | |
Phone | 1-800-777-4674 |
CustServ@mizuhosi.com | |
Phone | 1-800-777-4674 |
CustServ@mizuhosi.com | |
Phone | 1-800-777-4674 |
CustServ@mizuhosi.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00842430109188 [Primary] |
CCX | Support, Patient Position |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-09-08 |
Device Publish Date | 2025-08-29 |
00842430109188 - PRONECONNECT PROTECTIVE HELMET | 2025-09-08 |
00842430109188 - PRONECONNECT PROTECTIVE HELMET | 2025-09-08 |
00842430109195 - PRONECONNECT ADJUSTABLE HELMET | 2025-09-08 |
00842430109201 - PRONECONNECT COMBO PACK 4L, 3M, 3S | 2025-09-08 |
00842430109218 - PRONECONNECT LOW PROFILE MIRROR | 2025-09-08 |
00842430109225 - PRONECONNECT ADJUSTABLE MIRROR | 2025-09-08 |
00842430109232 - PRONECONNECT MIRROR WITH POST HOLES | 2025-09-08 |
00842430109249 - PRONECONNECT TRIOS MIRROR PLATFORM | 2025-09-08 |
00842430109256 - PRONECONNECT CUSHION INSERT, SINGLE, S | 2025-09-08 |